Senior Clinical Team Manager

3 semanas atrás

Sao Paulo, Brasil Thermo Fisher Scientific Tempo inteiro

PPD’s mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in-between, it’s you We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams.

Our global Clinical department consists of colleagues with institutional knowledge, in-depth therapeutic experience, and robust operational tools. Together, we help clients define and develop clinical programs, minimize delays and execute high-quality, cost-efficient clinical studies.

As a Clinical Team Manager (CTM), you combine deep knowledge, therapeutic expertise, and robust tools to help our clients deliver life-changing therapies to market. You take ownership, anticipate problems, find solutions and deliver results.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.

Summarized Purpose:
Accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer. Interprets data on complex issues and makes good business decisions with support from line management. Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. Typically works independently on projects of moderate to high complexity and may assume regional lead or Clinical Study Manager responsibilities.

Essential Functions:

- Manages all clinical operational and quality aspects of allocated studies, of moderate to high complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Lead CTM responsibilities on regional level, Clinical Study Manager (CSM) responsibilities or take on additional responsibilities; e.g. process improvements, manage complex programs, have wider management or project coordination responsibilities.
- Develops clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contributes to the development of the Master Action Plan (MAP) for providing clinical related documents. Ensures timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central). May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required. Collaborates with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.
- Collaborates with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicates with the team and leads team meetings to ensure that timelines, resources, interactions, and quality are maintained. Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies. Responsible for the timely archiving of documents and study materials for the department.
- Ensures achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution. Continuously monitors clinical trials to assess performance and ensure contractual obligations are met. May routinely conduct Accompanied Field Visits(AFVs) and be accountable for project financials.
- Communicates with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues.
- May coordinate all start-up activities and ensures that essential document quality meets the expectation of Regulatory Compliance Review. Ensures timely regulatory submissions (if appropriate) are addressed. Reviews and follows up on all questions raised by ethics committees. Responsibilities may vary based on project timelines.
- Provides input into preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements.
- In North America, where assigned to GPHS (Government & Public Health Studies) projects, may have limited line management responsibilities.

Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocation

  • Clinical Project Manager

    2 meses atrás

    Sao Paulo, Brasil CTI Clinical Trial Services, Inc Tempo inteiro

    **Clinical Project Manager** **(Level Depends on Experience)** **Job Purpose/Summary**: Responsible for management and oversight of assigned clinical trials (Phase I through Phase IV) to ensure client’s goals of time, budget and quality performance are met. The Clinical Project Manager I is expected to require support and guidance from Directors and/or...

  • Clinical Project Manager

    3 semanas atrás

    Sao Paulo, Brasil CTI Clinical Trial Services, Inc Tempo inteiro

    **Clinical Project Manager** **(Level Depends on Experience)** **Job Purpose/Summary**: Responsible for management and oversight of assigned clinical trials (Phase I through Phase IV) to ensure client’s goals of time, budget and quality performance are met. The Clinical Project Manager I is expected to require support and guidance from Directors and/or...

  • Clinical Team Manager

    3 semanas atrás

    Sao Paulo, Brasil Thermo Fisher Scientific Tempo inteiro

    At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...

  • Clinical Project Manager

    Há 3 dias

    São Paulo, São Paulo, Brasil CTI Clinical Trial Services, Inc Tempo inteiro

    Clinical Project Manager(Level Depends on Experience)Job Purpose/Summary: Responsible for management and oversight of assigned clinical trials (Phase I through Phase IV) to ensure client's goals of time, budget and quality performance are met. The Clinical Project Manager I is expected to require support and guidance from Directors and/or advanced Clinical...

  • Clinical Team Manager

    3 semanas atrás

    Sao Paulo, Brasil Thermo Fisher Scientific Tempo inteiro

    At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...

  • Clinical Project Assistant

    4 semanas atrás

    Sao Paulo, Brasil CTI Clinical Trial Services, Inc Tempo inteiro

    **Clinical Project Assistant** **Job Purpose/Summary** Responsible for supporting management efforts of Clinical Project Managers and Directors, ensuring timelines, and quality standards are being achieved. **What You’ll Do** - Support Clinical Project Manager / Director in completing management activities; supports activities through all phases of a...

  • Clinical Team Lead

    2 meses atrás

    São Paulo, Brasil Fortrea Tempo inteiro

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Clinical Team Lead

    Há 3 dias

    São Paulo, São Paulo, Brasil Fortrea Tempo inteiro

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas.With over 19,000 staff...

  • Clinical Team Lead

    2 semanas atrás

    São Paulo, Brasil SAO Fortrea Brazil Limitada Tempo inteiro

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Clinical Trial Manager

    Há 3 dias

    São Paulo, São Paulo, Brasil Iqvia Llc Tempo inteiro

    (Senior) Clinical Trial Manager - Sponsor Dedicated page is loaded (Senior) Clinical Trial Manager - Sponsor Dedicated Apply locations São Paulo, Brazil Mexico City, Mexico Santiago, Chile Buenos Aires, Argentina Lima, Peru time type Full time posted on Posted 2 Days Ago job requisition id R Clinical Trial Manager – Sponsor Dedicated. Clinical Trial...

  • Sr. Clinical Project Manager

    3 semanas atrás

    Sao Paulo, Brasil Novasyte Tempo inteiro

    IQVIA Biotech is seeking a Sr. Clinical Project Manager/Project Manager with experience working in Cardiovascular, Renal and/or Metabolic. Please include CV in English when applying: BASIC FUNCTIONS: Responsible for the successful planning, implementation and execution of contracted activities. Assures the accurate transfer of contracts from proposal through...

  • Senior Project Manager, Oncology

    Há 2 dias

    São Paulo, São Paulo, Brasil Worldwide Clinical Trials Tempo inteiro

    Requisition Number8089Employment Type:RegularSenior Project Manager, Clinical Project Management Therapeutic Experience Required:Oncology Location: While this role is remote/hybrid, candidates must residethe United States or Canada Who we are Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership...

  • Project Mgr/senior Project Mgr, Global Clinical

    4 semanas atrás

    Sao Paulo, Brasil Thermo Fisher Scientific Tempo inteiro

    We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving...

  • Project Mgr/senior Project Mgr, Global Clinical

    1 semana atrás

    Sao Paulo, Brasil Thermo Fisher Scientific Tempo inteiro

    We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving...

  • Project Mgr/senior Project Mgr, Global Clinical

    3 semanas atrás

    Sao Paulo, Brasil Thermo Fisher Scientific Tempo inteiro

    We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving...

  • Clinical Trial Manager

    3 semanas atrás

    Sao Paulo, Brasil ICON plc Tempo inteiro

    Job Advert Posting ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to...

  • Clinical Operations Manager

    1 semana atrás

    Sao Paulo, Brasil MSD Tempo inteiro

    **Job Description**: Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine. This role is accountable for performance and...

  • Clinical Trial Assistant

    2 meses atrás

    Sao Paulo, Brasil IQVIA Tempo inteiro

    Job Overview Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. Essential Functions - Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical...

  • Clinical Operations Manager

    2 semanas atrás

    Sao Paulo, Brasil MSD Tempo inteiro

    This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the Sr. COM, Head COMs or CRD, the person is responsible for...

  • Clinical Trial Assistant

    2 meses atrás

    Sao Paulo, Brasil Novasyte Tempo inteiro

    Job Overview Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. Essential Functions - Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical...